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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI NUCLEUS SIZE 1; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

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TORNIER INC TORNIER SIMPLICITI NUCLEUS SIZE 1; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM Back to Search Results
Catalog Number DWG401
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Limb Fracture (4518)
Event Date 05/02/2022
Event Type  Injury  
Manufacturer Narrative
Based on the available information the device remains implanted therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient suffered a intraoperative gt fracture that was treated with gt orif suture cerclage.
 
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Brand Name
TORNIER SIMPLICITI NUCLEUS SIZE 1
Type of Device
PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18381545
MDR Text Key331180208
Report Number0001649390-2023-00358
Device Sequence Number1
Product Code PKC
UDI-Device Identifier00846832091874
UDI-Public00846832091874
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberDWG401
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/06/2022
Initial Date FDA Received12/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
Patient SexFemale
Patient Weight95 KG
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